Predictive Value of Aortic Stiffness on Recurrence of Atrial Fibrillation After Disconnection of Pulmonary Veins (VARIABLE). (VARIABLE)

Predictive Value of Aortic Stiffness on Recurrence of Atrial Fibrillation After Disconnection of Pulmonary Veins.

The ablation of atrial fibrillation (FA) by disconnection of pulmonary veins is a burgeoning intervention. It allows a long-term treatment of this arrhythmia with a success rate of about 80%. There are, nevertheless, some recidivism.

Risk factors for recidivism are poorly codified and need further research. Indeed the identification of factors of poor prognosis could lead to not propose this procedure to the patients who present them and at least to inform them of an increased risk of failure.

To date, aortic stiffness has not been studied in the context of assessing the risk factors for FA recurrence after ablation. On a physiopathological level, the aortic stiffness leads to increase left ventricle's post-load. Cardiac remodeling was observed with diastolic dysfunction and increased left atrial size. That may constitute a substrate for FA recurrence.

In the literature, aortic stiffness can be measured in several ways:

1. Measurement of systolo-diastolic variation of the inner diameter of the aorta by scanner or transesophageal Echography (ETO).
2. Measuring of the Pulse Wave Velocity.
3. Measurement of aortic calcifications.

The investigators propose to evaluate the impact of aortic stiffness on the recidivism of FA 6 months after ablation procedure performed in the Croix-Rousse cardiology's department.

Study Overview

• Status: Unknown
• Conditions: First Ablation of Atrial Fibrillation

• Study Type: Observational
• Enrollment (Anticipated): 100

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69004
    • Recruiting
    • Hospices Civils de Lyon - Hôpital de la Croix Rousse
    • Contact: Pierre Lantelme; Phone Number: +33 4 72 07 16 67; Email: pierre.lantelme@chu-lyon.fr
    • Contact: Fatou Langevin; Phone Number: +33 4 72 07 28 65; Email: Fatou.langevin@chu-lyon.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient benefiting of a first Atrial Fibrillation's ablation by cryotherapy or radiofrequency within the Service of the Croix Rousse's hospital and having signed a consent for participate in this research.

Description

Inclusion Criteria :

• 18 years old of both sexes,
• Patient carrying a paroxysmal or persistent atrial fibrillation, benefiting from a first procedure of atrial fibrillation's ablation in the in the Croix-Rousse cardiology's department.
• Patient who signed the consent to participate in the study.

Exclusion Criteria :

• Patient carrying a permanent atrial fibrillation
• Patient who're in atrial fibrillation during the ablation
• Atrial fibrillation relapse's history after ablation
• Pregnant and nursing women
• Patients refusal.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Atrial fibrillation recurrences	Atrial fibrillation recurrences after 6 months of ablation by Holter ECG	Month 6

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Pierre Lantelme, Hospices Civils de Lyon - Hôpital de la Croix Rousse

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Anticipated): May 1, 2018
• Study Completion (Anticipated): May 1, 2018

Study Registration Dates

• First Submitted: July 20, 2017
• First Submitted That Met QC Criteria: July 20, 2017
• First Posted (Actual): July 24, 2017

Study Record Updates

• Last Update Posted (Actual): July 24, 2017
• Last Update Submitted That Met QC Criteria: July 20, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: Atrial Fibrillation; First Ablation
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Disease Attributes; Arrhythmias, Cardiac; Atrial Fibrillation; Recurrence
• Other Study ID Numbers: 69HCL17_0508

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No